FDA has announced the approval of liraglutide injections for treatment of type 2 diabetes among pediatric patients.
Novo Nordisk’s liraglutide injection (Victoza) received approval from the US Food and Drug Administration for treatment of type 2 diabetes (T2D) in pediatric patients 10 years or older.
It becomes the first non-insulin drug approved to treat T2D in pediatric patients since metformin was approved for pediatric use since metformin in 2000. The FDA had previously granted the application priority review status and approved liraglutide for treatment of T2D in adult patients in 2010.
“Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease,” said Lisa Yanoff, MD, acting director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research.
Approval is based on demonstrations of efficacy and safety for reducing blood sugar in patients with T2D from a placebo-controlled trial with 134 pediatric patients 10 years in older who received liraglutide for more than 26 weeks. Investigators noted that 64% of patients in the study had a reduction in A1C below 7% while on liraglutide compared to only 47% who achieved these results with placebo.
It was noted that pediatric patients taking liralglutide had a higher risk of hypoglycemia regardless of whether they took other therapies for diabetes. Prescribing info for liraglutide includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors.
Liraglutide received approval in 2017 for indications to reduce the risk of major adverse cardiovascular events in adults with T2D and established cardiovascular disease. The effect of liraglutide on major adverse cardiovascular events in pediatrics was not studied and it is not indicated for this use in children.